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NCT Number: NCT06427317

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

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Key information

Conditions

Infections, Bacterial Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Drug Monitoring Drug-Related Side Effects and Adverse Reactions Infections Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance.

Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection.

This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies.

Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or above.

  • Under follow-up for management of infection at Imperial College NHS Trust
  • Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).
  • Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):
  • Delirium which may be caused or exacerbated by having an infection.
  • Suspected/confirmed central nervous system infection.
  • Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection.

Exclusion criteria

  • Less than 18 years of age
  • Severe anaemia (Hb < 70g/l)
  • Platelets < 50x10^9/l, INR >1.5 or other known blood clotting impairment
  • Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.
  • Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
  • Patients with restricted liberty, prisoners or under legal protection.

Treatment and study plan

Primary outcomes

  1. Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

    Time frame: 3 years

    Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved

Secondary outcomes

  1. Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.

    Time frame: 3 years

    Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.

  2. Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.

    Time frame: 3 years

    Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.

  3. Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.

    Time frame: 3 years

    Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.

  4. Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.

    Time frame: 3 years

    Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.

  5. Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies

    Time frame: 3 years

    Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies

Study contacts

Contact information is provided by the study sponsor or research team.

Richard Wilson, MPharm

CONTACT

[email protected]

Suzy Williams

CONTACT

[email protected]

+44 (0) 20 3313 2732

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management

Acronym: DATATDM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 23, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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